Laser Therapy in Managing Vaginal Prolapse

September 15, 2019 updated by: Themos Grigoriadis, National and Kapodistrian University of Athens

Management of Vaginal Prolapse Using Laser Therapy: Randomized Controlled Trial

Efficacy of laser therapy in postmenopausal women with symptomatic prolapse stage >1. Assessment tools will include prolapse stage quantification system (POP-Q) and validated condition related questionnaires.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Postmenopausal women with symptomatic cystocele and/or rectocele stage 2 or 3 will be 1:1 randomly allocated to Er:YAG laser or watchful waiting group. Participants in the Er:YAG laser group will receive laser therapies at monthly intervals, while participants in the watchful waiting group will receive no treatment. All outcomes in both groups will be evaluated at baseline, 4-months and 6-months from baseline.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11528
        • Urogynecological Unit of Alexandra Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Symptomatic prolapse stage >1 (cystocele, vaginal vault prolapse, enterocele, rectocele) according to POP-Q System
  • Negative Pap-smear

Exclusion Criteria:

  • Asymptomatic prolapse
  • prolapse stage <=1
  • prolapse of uterus
  • presence of any type of genital infections (i.e herpes, vaginitis etc)
  • vaginal bleeding
  • underlying pathologies that could interfere in patients compliance (i.e psychiatric)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No intervention
Experimental: Laser
Erbium Yttrium Aluminum Garnet (Er:YAG) laser therapies
Device: Erbium Yttrium Aluminum Garnet (Er:YAG) laser
5 Er:YAG laser therapies vaginally administered at monthly intervals
Other Names:
  • Fotona

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic Organ Prolapse Quantification System (POP-Q)
Time Frame: Change from baseline to 4-6 months
Physical examination
Change from baseline to 4-6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic Floor Distress Inventory Short Form (PFDI)
Time Frame: Change from baseline το 4-6 months
Total score is calculated by adding the scores of 3 scales (Urogenital Distress Inventory (UDI)-6, Pelvic Organ Prolapse Distress Inventory (POPDI)-6 and Colorectal Anal Distress Inventory (CRADI)-8) with a possible range from 0 to 300. Each scale-item could receive values from 0 to 4 applying to a score ranging from 0 to 100 for each scale. The higher the score the more intense are the symptoms.
Change from baseline το 4-6 months
International Consultation on Incontinence Modular Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
Time Frame: Change from baseline to 4-6 months
It is a 12-items questionnaire evaluating nocturia, urgency, bladder pain, frequency, hesitancy, straining, intermittency, urinary incontinence (UI) (urge, stress and unexplained), frequency of urinary incontinence and nocturnal enuresis. Filling, voiding and incontinence symptoms subscales range from 0 to 15, 0 to 12 and 0 to 20, respectively. Additionally, it evaluates impact of individual symptoms with bothering scales that are not incorporated in the overall scores.
Change from baseline to 4-6 months
Pelvic Floor Impact Questionnaire short Form
Time Frame: Change from baseline to 4-6 months
Includes 3 domains (incontinence impact questionnaire (IIQ), Pelvic Organ Prolapse Impact Questionnaire (POPIQ) and Colorectal-anal Impact Questionnaire (CRAIQ) with overall 21-items (7 items in each domain). The total score of PFIQ-7 ranges from 0 to 300 (each domain may receive scores from 0 to 100). The highest the score the greater is the impact
Change from baseline to 4-6 months
Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Short form
Time Frame: Change from baseline to 4-6 months
It includes 12 items corresponding to behavioral-emotive, physical and partner related domains. Likert scale ranging from always (0 score) to never (4 score) is encompassed. Scores are obtained for all domains individually. The sum of all scores create a total PISQ score. PISQ total score range from 0-125. Higher values indicate better sexual functioning.
Change from baseline to 4-6 months
Patients Global Impression of Improvement
Time Frame: 4-6 months
It is a single-item questionnaire aiming to evaluate patients impression of improvement following therapeutic intervention.
4-6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: Up to 3 months post-treatment
Women will be asked to keep a diary reporting any adverse events occuring.
Up to 3 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Investigators

  • Study Director: Stavros Athanasiou, Associate Proffesor, National and Kapodistrian University of Athens, Greece

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2018

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

October 13, 2018

First Submitted That Met QC Criteria

October 19, 2018

First Posted (Actual)

October 22, 2018

Study Record Updates

Last Update Posted (Actual)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 15, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 310/26-04-2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cystocele

Clinical Trials on Erbium Yttrium Aluminum Garnet (Er:YAG) laser

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe